Third Degree HemorrhoidsPhase 4NCT01263431
Comparison Between Excisional Hemorrhoidectomy and Haemorrhoidal Dearterialisation With Anopexy
A Phase 4 study testing Hemorrhoidectomy and Hemorrhoidal dearterialization in people with Third Degree Hemorrhoids, run by Scientific Institute San Raffaele at 1 site in Italy.
Trial summary
Aim of the study is to compare short term results of 2 surgical treatment for grade 3 hemorrhoidal disease, namely: pain and postoperative morbidity,complications and effectiveness within 30 days, re-starting daily and working activity, patients' satisfaction Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Third Degree Hemorrhoids
- What is being tested?
- Hemorrhoidectomy and Hemorrhoidal dearterialization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2010to Apr 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80, candidate to surgery for 3rd degree hemorrhoids
Who cannot join
- Previous anal surgery or pelvic radiotherapy
- Fecal incontinence or obstructed defecation
- IBD, IBS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Trial on Surgical Treatment of Grade 3 Hemorrhoids: Hemorrhoidectomy Versus Doppler-guided Transanal Haemorrhoidal Dearterialisation and Anopexy
Aim of the study is to compare short term results of 2 surgical treatment for grade 3 hemorrhoidal disease, namely: pain and postoperative morbidity,complications and effectiveness within 30 days, re-starting daily and working activity, patients' satisfaction
Read the detailed description
Excisional haemorrhoidectomy is burdened by severe postoperative pain. For this reason less painful treatments have been developed, such as Doppler-guided haemorrhoidal artery ligation and stapled anopexy. Both techniques seem to be safe, causing little postoperative pain. A combination of the two techniques could possibly treat both bleeding and prolapse with minimal discomfort
- Conditions
- Third Degree Hemorrhoids
- Being tested
- Hemorrhoidectomy, Hemorrhoidal dearterialization
- Keywords
- Hemorrhoidectomy, haemorrhoidal dearterialisation, anopexy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemorrhoidectomyProcedure or surgery
Each of the main haemorrhoid is dissected and the apex is ligated and then cut, near to the dentate line
Hemorrhoidal dearterializationProcedure or surgery
A special instrument (THD, G.F., Medical Division, Correggio, Italy )with an incorporated Doppler probe is used to detected the six terminal branches of the superior rectal artery which are ligated above the dentate line, then a running suture is performed in order to obtain a mucopexy
| Study group | Role | What they receive |
|---|---|---|
| Hemorrhoidectomy | Active comparator | Excision of hemorrhoid cushions Receives: Procedure: Hemorrhoidectomy |
| Hemorrhoidal dearterialization | Experimental | Ligation of therminbal branches oh hemorrhoid arteries Receives: Procedure: Hemorrhoidal dearterialization |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Measured: 1 week
Secondary outcomes (4)
postoperative morbidity
Measured: 30 days
resumption of working activity
Measured: 30 days
patient's satisfaction
Measured: 30 days
Relapse
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Third Degree HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scientific Institute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paola De Nardi, Scientific Institute San Raffaele
- Investigators
- Paola De Nardi, MD, Principal investigator, San Raffaele Scientific Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263431
- Sponsor's protocol ID
- Emorroidi grado 3
- Status last verified
- Jan 2015
- First submitted
- 17 Dec 2010
- Last updated
- 22 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
De Nardi P, Capretti G, Corsaro A, Staudacher C. A prospective, randomized trial comparing the short- and long-term results of doppler-guided transanal hemorrhoid dearterialization with mucopexy versus excision hemorrhoidectomy for grade III hemorrhoids. Dis Colon Rectum. 2014 Mar;57(3):348-53. doi: 10.1097/DCR.0000000000000085.
PubMed 24509458
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial on Surgical Treatment of Grade 3 Hemorrhoids: Hemorrhoidectomy Versus Doppler-guided Transanal Haemorrhoidal Dearterialisation and Anopexy
- ClinicalTrials.gov ID
- NCT01263431
- Acronym / sponsor ID
- Emorroidi grado 3
- Conditions
- Third Degree Hemorrhoids
- Keywords
- Hemorrhoidectomy, haemorrhoidal dearterialisation, anopexy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Scientific Institute San RaffaeleUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 20 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study is to compare short term results of 2 surgical treatment for grade 3 hemorrhoidal disease, namely: pain and postoperative morbidity,complications and effectiveness within 30 days, re-starting daily and working activity, patients' satisfaction
Detailed description
Excisional haemorrhoidectomy is burdened by severe postoperative pain. For this reason less painful treatments have been developed, such as Doppler-guided haemorrhoidal artery ligation and stapled anopexy. Both techniques seem to be safe, causing little postoperative pain. A combination of the two techniques could possibly treat both bleeding and prolapse with minimal discomfort
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemorrhoidectomy | Active comparator | Procedure: HemorrhoidectomyExcision of hemorrhoid cushions |
| Hemorrhoidal dearterialization | Experimental | Procedure: Hemorrhoidal dearterializationLigation of therminbal branches oh hemorrhoid arteries |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-80, candidate to surgery for 3rd degree hemorrhoids
Key exclusion criteria (3 listed)
- Previous anal surgery or pelvic radiotherapy
- Fecal incontinence or obstructed defecation
- IBD, IBS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemorrhoidectomyEach of the main haemorrhoid is dissected and the apex is ligated and then cut, near to the dentate line | Procedure or surgery | Hemorrhoidectomy |
| Hemorrhoidal dearterializationA special instrument (THD, G.F., Medical Division, Correggio, Italy )with an incorporated Doppler probe is used to detected the six terminal branches of the superior rectal artery which are ligated above the dentate line, then a running suture is performed in order to obtain a mucopexy | Procedure or surgery | Hemorrhoidal dearterialization |
Primary outcome
postoperative pain
Time frame: 1 week
4 secondary outcomes
postoperative morbidity
Time frame: 30 days
resumption of working activity
Time frame: 30 days
patient's satisfaction
Time frame: 30 days
Relapse
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2015.
- Derived from this study: PubMed 24509458De Nardi P, Capretti G, Corsaro A, Staudacher C. A prospective, randomized trial comparing the short- and long-term results of doppler-guided transanal hemorrhoid dearterialization with mucopexy versus excision hemorrhoidectomy for grade III hemorrhoids. Dis Colon Rectum. 2014 Mar;57(3):348-53. doi: 10.1097/DCR.0000000000000085.
Related trials for Third Degree Hemorrhoids
Not yet recruitingPhase 2
Comparing Rectal Artery Embolization and Surgery for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids
Hemorrhoids Internal, Hemorrhoids Second Degree
Recruiting
HELO Trial: Energy-Based Therapies vs. Conventional Hemorrhoidectomy for Grade III Hemorrhoids
Hemorrhoids Third Degree, Internal Hemorrhoids
Recruiting
PUSHES (Pudendal Block Versus Sacral ESP Hemorrhoidectomy Study)
Hemorrhoids, Hemorrhoids Third Degree
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paola De Nardi, MD principal investigator
San Raffaele Scientific Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hemorrhoidectomy and Hemorrhoidal dearterialization in people with Third Degree Hemorrhoids, run by Scientific Institute San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01263431, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2015.